|- candidate number||24204|
|- NTR Number||NTR5712|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-apr-2016|
|- Secondary IDs||ZonMw/SBOH 839110015|
|- Public Title||Online treatment for older dizzy patients in general practice|
|- Scientific Title||Internet-based vestibular rehabilitation for older dizzy adults: does it work? A single blind, three arm, randomised controlled trial in general practice|
|- ACRONYM||VERTIGO (VEstibular Rehabiliation Therapy: Internet-based treatment in General Practice for Older adults)|
|- hypothesis||Stand-alone internet-based Vestibular Rehabilitation (VR) and internet-based VR with physiotherapeutic support is more (cost-)effective than usual care when treating dizziness in older patients in general practice.|
|- Healt Condition(s) or Problem(s) studied||Dizziness|
|- Inclusion criteria||a. Aged 50 years and over.|
b. Reported symptoms of dizziness.
c. Head movements increase the dizziness.
d. Acces to internet and an email account.
e. Ability to speak, read and write Dutch.
|- Exclusion criteria||a. An identifiable non-vestibular cause of dizziness in the electronic record of the patient.|
b. Medical contraindications for making the required head movements (for example, severe cervical arthrosis).
c. Serious comorbid conditions that preclude participation in an exercise programme.
d. Current enrolment in another – interfering – study.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2016|
|- planned closingdate||28-feb-2021|
|- Target number of participants||300|
|- Interventions||We will compare stand-alone internet-based VR (trial arm 1, N=100) and internet-based VR with physiotherapeutic support (trial arm 2, N=100) with usual care (trial arm 3, N=100). The internet-based VR intervention closely resembles on the effective booklet-based VR by Yardley et al (BMJ 2012).
VR entails specific exercises with the aim of maximising central nervous system compensation for vestibular pathology. Recently, specific components have been defined, namely compensation (using motion to habituate or reduce responsiveness to repetitive stimuli and to re-balance tonic activity within the vestibular nuclei), adaptation (using repetitive and provocative movements of the head and/or eyes to reduce error and restore vestibule-ocular reflex gain), substitution (promoting the use of individual or combinations of sensory inputs), and motor learning principles (changing movement behaviour). |
|- Primary outcome||1. Dizziness symptoms at six months -> Vertigo Symptoms Scale-Short Form (VSS-SF)|
2. Health economic outcomes -> iMTA Medical Consumption Questionnaire (iMCQ)
|- Secondary outcome||1. Dizziness-related impairment -> Dizziness Handicap Inventory|
2. Subjective improvement in dizziness symptoms (SI)
3. Anxiety or depression -> Patient Health Questionnaire
4. Adherence to treatment -> Problematic Experiences of Therapy Scale
|- Timepoints||Inclusion: June 2017 -May 2018.|
Follow-up: September 2017 - November 2018.
Measurements: at baseline, 3 months, and 6 months follow-up.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. O.R. Maarsingh|
|- CONTACT for SCIENTIFIC QUERIES||Dr. O.R. Maarsingh|
|- Sponsor/Initiator ||VU University Medical Center, EMGO Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||7-apr-2016 - 28-apr-2016|